Senior/Principal Scientist, Formulation and Process Development

🔥 0 minutes ago

❄️ Minnesota – Remote

❄️ Minnesota – Remote

💵 $150k - $175k / year

⏰ Full Time

🟠 Senior

🧬 Research Scientist

👻 Ghost score 3%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Celcuity

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Celcuity is a clinical-stage biotechnology company developing targeted therapies that block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor being evaluated in breast and prostate cancer trials. The company advances a focused pipeline aimed at delivering transformative, targeted cancer treatments and conducts clinical development and data-driven research to support regulatory and medical adoption.

📋 Description

• Lead projects supporting novel and existing formulations across the product lifecycle, including pre-formulation, dosage form selection, formulation development, process development, and manufacturing scale-up • Design, execute, and interpret formulation and process development experiments in outsourced environments at contract laboratories and CDMOs • Identify and vet new contract organizations for formulation and process development • Help define and execute project plans for formulation lifecycle management • Support writing technical sections for intellectual property and regulatory filings • Develop and maintain in-depth knowledge of formulation development trends, techniques, and technologies • Serve as a subject matter expert for formulation development within the Pharmaceutical Development group and broader Celcuity team • Summarize, document, and present information to subgroup, group, and cross-functional audiences • Perform other duties as assigned

🎯 Requirements

• Ph.D., M.S., or B.S. in Pharmaceutical Science, Chemical Engineering, Chemistry, Biochemistry, Biochemical Engineering, or related fields • 7+ years of experience in pharmaceutical development; preferred industry experience of 4+ years for Ph.D., 5+ years for M.S., or 7+ years for B.S. • Demonstrated experience with formulation development and drug product development, preferably for small molecule drugs • Deep understanding of formulation techniques and considerations for sterile, parenteral dosage forms • Knowledge of other dosage forms, such as ophthalmic or oral, beneficial • Experience with drug-device combination products for injectable drug products preferred • Technical expertise in formulation strategies and processes for poorly water-soluble APIs preferred • Subject matter expertise in nano-milling and nanosuspension formulation, micro/nano-emulsions, salt formation and salt screening/selection, complexation and co-solvency using cyclodextrins or co-solvents, or lyophilization highly desirable • Experience with physicochemical characterization methods for drug substances and drug products • Experience with preclinical study support and early-stage formulation development • Excellent written and verbal communication skills • Strong interpersonal skills • Attention to detail and ability to manage multiple processes and documentation requirements • Strong technical and analytical skills with advanced knowledge in MS Office products • Ability to work in a team or independently • Outstanding organizational and prioritization skills • Independent and sound decision-making skills; ability to think critically in a fast-paced environment • Flexible, willing to learn, and able to adapt to business and site needs • Positive, approachable, and professional attitude

🏖️ Benefits

• Annual performance incentive bonus • New hire equity package • Medical insurance • Dental insurance • Vision insurance • 401(k) match • PTO • Paid holidays